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When his company received a hefty order from a Swedish importer in
August 2000, Prem Raj Tiwari rejoiced with much enthusiasm at a
relatively big business deal. The single largest export order the
company ever had for ayurvedic products — processed medicinal herbs
— had strengthened his aim of reviving the company’s languishing export
trade by cashing in on the flourishing world demand for herbal products.
But Tiwari’s enthusiasm was soon dashed when he received an e-mail
from his Narkayrd-based Swedish counterpart withdrawing the order. The
mail stated that the company’s product samples did not pass the ‘satisfactory
and sufficient’ sanitary and quality standard tests for access to the
Swedish market. Moreover, Tiwari was astonished to learn of the
requirement for a certificate of good manufacturing practices (GMP) for
each consignment.

Until this incident, Tiwari had not been aware of the requirements
for such a specific test and the GMP certificate in order to be able to
export the company’s products. The GMP is a system of quality
assurance and quality control not only for the products themselves but
also for the pre- and post-manufacturing processes to ensure sanitation
and the minimization of the risks inherent in food and medicinal
production, processes which cannot be assessed by only testing the final
products.

Tiwari’s company, the Gorkha Ayurved Co. —
a joint venture between
Nepalese and French investors — had gained about 6% of the domestic
market for herbal products. One of the major products of the company was
the herbal tea sold under the established brand name Guduchi, known as a
health drink. The popularity of Guduchi had, in fact, tempted other
herbal firms into imitation of the brand name. Other key products
manufactured by the company were about fifty herbal remedies, based on
ayurvedic medicines or traditional health science. Satisfied with the
sales volume in the local market, which allowed the company to break
even, Tiwari, the managing director, contemplated good prospects for the
export of ayurvedic medicines, as he had received business inquiries
from Germany, France, Italy, Sweden, the Czech Republic and Australia
over the previous couple of years.

Since Tiwari joined the company as a financial consultant in 1999, he
had seen tremendous scope in this sector, for two main reasons. First,
the international demand for herbal products was growing at an annual
rate of 10% on average, and the global market for herbal medicines was
expected to reach US$16 billion by 2005, according to a recent study.
Second, Nepal had witnessed a smooth growth trend in export of herbal
products, indicating one of the most potential areas of comparative
advantage. That had resulted in an increased number of foreign investors
— particularly the popular Indian herbal product manufacturers — being
attracted to Nepal to exploit the country’s favourable climate and
abundance of a wide variety of aromatic plants and medicinal herbs.
Nepal is endowed with more than 700 species of medicinal and aromatic
plants, of which 250 species are endemic. These companies had firmly
established backward and forward linkages and had exported products made
from Nepalese herbs under their own brand names. However, Nepal’s
share in the global market for the product range remained minuscule,
despite promising signs.

Although the share of herbal products in Nepal’s export basket
seemed to be modest, Tiwari expected three points of comparative
advantage for his company to boost trade in this product line. First,
the export of herbal products, including the ayurvedic remedies, did not
have to face stiff price competition due to a limited number of
suppliers in the world market. Second, these products had been enjoying
duty advantages, as they were exempted from the customs duties under the
generalized system of preferences (GSP) applying to Nepalese goods in
all major international markets. Third, ayurvedic remedies had been
noticeably concentrated in the European markets that accounted for
almost half of the global demand for herbal remedies: Germany and France
were the most prominent markets in Europe.

Despite these advantages the Swedish importer’s requirement had,
for the first time, put Tiwari in a very complicated situation if he was
to strike a successful export business deal. If his company’s products
were to gain access to the Swedish market, they needed to undergo tests,
in particular for organochloropesticide, fungicide and heavy metal, but
also other detailed microbiological tests, which were not easily
available in Nepal. In addition, the requirement of the ‘stringent’
GMP certification had come as a surprise to him, as he had hitherto been
used only to basic laboratory tests for sanitary certificates.

In the meantime Tiwari was surprised to get an order in October 2001
from a Sydney-based importer who did not seek any such complicated tests
and certification. Only a general sample test was required for the
products, which were exported in the form of a single ingredient in
powder form, before entering the Australian market. Since then, Gorkha
Ayurved had regularly been exporting wide varieties of ayurvedic
remedies without any stringent requirements.

Baffled by the two different quality and sanitary requirements for
the same product range, Tiwari at first thought that the Swedish
importer’s conditions were ‘arbitrary’ and intended as barriers to
trade in the importing country. Similarly, he was bewildered by the
application of ‘double standards’ in international trade and
reckoned that the buyers’ requirements could possibly impede his
company’s export endeavours.

But soon he learned that the buyers could ask for compliance with
international standard under the WTO’s Sanitary and Phytosanitary
Measures (SPS) Agreement. That is because the WTO recognizes
internationally harmonized standards and encourages member countries to
use them as a basis for their SPS measures in order to reduce
distortions in market access. The SPS Agreement is consistent with the
standards and guidelines of the FAO and WHO with respect to food
additives, pesticide residues, contaminants, hygienic practices and
methods of analysis and sampling for harmonizing international rules in
this field of trade.

Thus, contrary to his initial perception, Tiwari discovered that his
Swedish counterpart’s requirement for GMP was in conformity to the
international standards. The GMP code, developed by WHO, was in fact the
internationally harmonized system for assuring quality and sanitary
standards in trade related to medicinal products. In a number of
advanced countries all herbal products were strictly required to be made
under the GMP code. No wonder he then understood why the code of GMP had
become a common requirement. Regarding the two different standards
requirements, he was assured that the Australian importer was entitled
to use less strict standards if they were still considered to be
sufficient.

In such a situation, Tiwari understood that he had no choice other
than to prepare his company to meet the international sanitary and
quality standards under the guidance and support of the domestic system
if he did not want to lose any lucrative business order in the future.
Regarding the export of ayurvedic remedies he came to know that without
the assurance of the GMP certification it wouldn’t be that simple to
win importers’ hearts and get through the border regulations in
importing countries.

Buyers in Western countries had increasingly been asking for GMP
certificates for aryurvedic remedies, as these products were relatively
vulnerable to contamination and unwanted substances. Meeting the quality
assurances for ayurvedic remedies was comparatively complicated, because
they were prepared from material of plant origin which might be exposed
to a higher risk of contamination and deterioration. Unlike conventional
pharmaceutical products, they may vary in composition and properties, as
well as in the application of procedures and techniques. Apparently
there was no exact surveillance system to be followed internationally as
to standard and quality control in ayurvedic medicines. However, GMP had
been considered as a basis of sanitary standards for this product
category. Failure to comply with the requirements by importers in the
respective countries had resulted in severe consequences: penalties,
confiscation and even the rejection of consignments.

‘If international buyers were entitled to ask for the quality and
sanitary assurances according to the internationally recognized system,
the exporters were then obliged to meet the requirement if they wanted
to avoid market access complications in importing countries, and to
retain exporter’s positions in international markets for products like
ayurvedic remedies, which indicated an increasing trend’, Tiwari
asserted. Keeping that in mind he contacted the Royal Drug Research Lab
(RDRL), the government-owned drug quality control authority, and the
Department of Food Technology and Quality Control — DFTQC (previously
the Central Food Research Laboratory), the responsible government body
for the inspection and accreditation of food standards, to find out if
they could be of any help in preparing his company for the buyers’
requirements.

Unfortunately, Tiwari found both institutions
without any plan or policy regarding SPS standards, including the GMP
certification procedures, particularly with regard to the export of
products in the herbal and ayurvedic category. Although Nepal was in the
process of acceding to the WTO at that time, no serious efforts were
being made on policy or the institutional framework for the SPS
requirements. That had resulted in a more confused situation for
exporters, including Gorkha Ayurved, posing complex questions for export
promotion strategy. ‘How could we exploit the country’s comparative
advantage if the authorized bodies lacked the vigilance and departmental
co-ordination to guide exporters and enforce the system recognized
internationally, in the wake of Nepal’s accession to the WTO?’
Tiwari lamented as his problem was left unresolved.

But with endorsement of Nepal’s membership
to the WTO at the Cancún Ministerial in September 2003 there were
reasons for Tiwari to be optimistic about his endeavour. In its
accession negotiations Nepal had committed to full implementation of the
SPS requirement by 1 January 2007. For that reason His Majesty’s
Government of Nepal (HMG) has designated the DFTQC as the national
enquiry point for SPS. The DFTQC, which enforces food-related laws and
code of conduct, had now been made responsible for initiating
co-ordination between the government departments and the private sector
regarding the implementation of the international SPS mechanism.
Following that the department had expedited efforts to synergize the
network and had developed a departmental structure to function
effectively as the SPS national inquiry point by 2004. That required the
DFTQC to implement the risk assessment mechanism and the pest detection
and eradication campaigns, including the strict quarantine procedures to
support Nepalese exporters in meeting the SPS standards. Among other
important steps taken by the Department was promoting the awareness of
FAO and WHO quality and sanitary systems among all stakeholders, to be
followed by the application of the basic rules and then the
fully-fledged operation of the FAO rules and WHO GMP standards in Nepal.
The Department as a focal point had also actively participated in the
aim of the member states of the South Asian Association for Regional
Co-operation (SAARC) of implementing the FAO/WHO systems within the
region by 2005.

As Tiwari went on inquiring, he found out that
the Department of Drug Administration (DDA), which enforces
pharmaceutical standards and quality control in Nepal, was the proper
government authority to deal with the SPS system for ayurvedic remedies.
However, since the DFTQC had been designated as the national SPS inquiry
point, the DDA was supposed to co-ordinate with the former for policy
implementation and monitoring GMP standards for products related to
remedies.

Interestingly, Tiwari was surprised to know
that the DDA had already made GMP mandatory for the importing of all
kinds of drug-related products into Nepal since 2000. Also it had
voluntarily imposed the GMP on the domestic pharmaceutical
manufacturers. As soon as Nepal had acceded to the WTO, the DDA had
informally instructed all pharmaceutical manufacturing companies,
including the herbal medicinal producers, to abide by the WHO GMP code
by the end of 2006, as a prerequisite to the SPS mechanism.

With that policy in the offing the DDA and the
medicinal manufacturers both had obligations to meet. The DDA as an
executing government body should have prepared itself for the
accreditation of GMP certification in the country. Its organizational
structure should have been strengthened to achieve the inspection and
auditing capacity for effectively monitoring and evaluating the system.
Additionally, it should have developed mechanisms to determine the basic
requirements to be fulfilled by the firms which were obliged to operate
under the GMP system. The criteria to be developed included the
selection and approval of site designs, equipment selection guidelines,
performance qualifications and data processing. As part of the capacity
development programme, its staff have been trained by foreign experts to
mobilize them as GMP auditors.

On the part of the industrial sector,
businesses were required to develop the GMP-related physical facilities
and implementation know-how themselves. These were supposed to be the
preconditions for being officially certified for the system. Of the
thirty-eight pharmaceutical manufacturers in the country, six had
already made preparations for conformity with GMP before the deadline
and had already requested inspection and certification from the DDA.

Although it took some time, Tiwari’s
untiring investigation had made him acquainted with the significance of
the GMP system and its policy issues. ‘Yet almost all herbal and
ayurvedic manufacturers had remained unaware of its necessity because
there were no genuine authorities to help them and because they lacked
business advocacy skills especially within the industry concerned’,
Tiwari said. Nevertheless, it seemed to him that it would be worth
taking his company under the GMP system to be compatible with the SPS
requirements, in order to avert market access barriers in other
countries and also to achieve his ambition to promote exports. His
exploration of the system and policy matters gave him enough ideas for
taking the necessary actions.

First of all, Tiwari raised the issue at a
meeting of the company’s board of directors. The meeting had been
called to discuss the possibility of shifting the company’s final
processing units from Gorkha district, where its entire manufacturing
processes had been taking place, to Kathmandu, for direct supervision.
He took this opportunity to inform the other board members about the
importance of SPS requirements and advised the building of the necessary
infrastructures within the proposed plan for compliance with the GMP and
SPS systems. The board members approved Tiwari’s proposal without any
hesitation.

Accordingly, Gorkha Ayurved launched the
project by purchasing land in Kathmandu. It planned to utilize the
company’s capital reserve and external financing to meet the ‘huge’
project cost, estimated at Rs 25 million (approximately US$338,000).
Tiwari informed us that ‘We had contacted a specialist from Italy for
the consultancy services on GMP technical inputs, among others. It
required additional funding of Rs 900,000 (US$12,000) for a month of
services that would be an extra financial burden to the company.’ If
the financial constraint was not an obstacle and the government was
fully committed to the policy implementation, Gorkha Ayurved would be
equipped with the GMP process to meet the international SPS standards
within the stipulated time — Tiwari was confident about that.

I encountered difficulties in meeting the
importers’ requirements that inspired me to delve into the issue of
quality and sanitary standards in international trade. It was
indispensable for me to gain in-depth knowledge about the application of
the provisions, domestically and internationally, in order to overcome
the market access problem to meet my goal for export promotion.

Without a constant follow-up and vigilance I
wouldn’t have successfully convinced the company board members about
the benefit of assembling the GMP facility within my company’s
proposed plan to build a processing unit in Kathmandu. Of course, the
DDA’s instruction for GMP application and Nepal’s systemic
commitment to full implementation of the SPS measures in its accession
protocol to WTO membership had actually given me ample reasons to raise
the issue at the company board meeting.

I think that was the key to success for getting
approval from the board to make the company prepare itself for the
internationally recognized standards, despite the initial requirement of
huge financial and technical investments.

Including the constraints of initial investments
to the companies like mine, there were a number of internal challenges
to effectively implement the SPS standards. First of all, the government’s
commitment to meet the SPS regulation within the stipulated timeframe
can only be determined by the financial resources and technical
expertise at its disposal.

He pointed to one of the studies that
calculated that the Nepalese government was seeking more than US$12
million to introduce an improved SPS regime. ‘It’s difficult for the
government to easily adopt the internationally recognized policy and
build capacity for the purpose unless financial and technical assistance
from international donors is forthcoming.’

The government has received assurances of
support from different international donors. Remarkably, the European
Union (EU) had approved technical assistance for SPS national capacity
building for Nepal. Tiwari’s suggestion was that the technical
assistance should at the same time be diverted to develop the DFTQC as
the fully-fledged SPS national inquiry point and to the
capacity-building of the SPS-related departments, including the DDA,
which was the body responsible for enforcing the GMP.

Tiwari commented that ‘The private sector
should also benefit from the technical assistance, as it had an immense
role to play in the awareness and business advocacy on Nepal’s entry
into the WTO and its commitment to the SPS mechanism. Many stakeholders,
including the business community, thought they did not have roles to
play in the multilateral trading system. They need to be able to
understand the possibility of unfavourable consequences in international
business if trade rules are not well understood.’

There were two things to be done urgently in
this regard. First of all there should have been regular
government-private-sector interactions to exchange their views on the
multilateral trading system. One of the objectives of the purpose should
have been to listen to the voice and concerns of the Nepalese business
community. However, that would not have been achieved until the
private-sector associations came forward to lead in their respective
fields.

Considering the rapidly changing global trading environment, Tiwari
recently took the initiative in establishing the Ayurvedic Medicine
Producers Association of Nepal (AMPAN). He has assumed the post of
general secretary of the association with much pride.

But it is early days yet and there is still much the Association
hopes to achieve in advocating the needs of its members.